Saturday, October 09, 2010

Yesterday evening, I met with Rex Richmond (Vice President of Marketing) and Dan Schlewitz (Executive Vice President U.S.A. Sales) from Biotronik, Inc. to hear their side of the controversy surrounding the withdrawal of a case report previously published in Europace pertaining to an "exploding" Biotronik implantable cardiac defibrillator (ICD). They claimed they have been transparent regarding the reporting of this incident to the FDA, filing their incident report with the FDA within seven days of the event (within thirty days is required). Mr. Richmond granted me permission to release their internal company memo (pdf) circulated to their employees regarding the case report.

I must supply several comments.

First, regarding why the case report was withdrawn, they state in their memo:

The author reported that after submitting the case report to Europace in June, further analysis was conducted but not included in the original report. As such, there are inaccuracies that need to be corrected. Specifically, the author stated that the term "explosion" was not accurate given that the device was distorted, but had not exploded as previously described. The author also observed that while this is the first such incident with a BIOTRONIK device, it is not in fact the first experience of a battery overheating in the industry.

Note that the updated MDA was submitted to the FDA 6 June 2010. The published article was submitted to Europace 29 June 2010 and accepted after revision 16 August 2010. Wouldn't these "inaccuracies" have been corrected with the revisions submitted back to Europace following their review well before the 27 Sep 2010 publishing date?

Second is the issue of FDA reporting mentioned in the memo:

Where do reports like this end up? Aren’t they public?

Yes, they do become public. The FDA posts MDR’s to their online Manufacturer and User Facility Device Experience (MAUDE) database at the following address:

(ed: Emphasis mine) Although the FDA has our MDR, it has yet to be posted to the database.

I do not know why the FDA would not have published the MDA's received in May with revisions in June on their website by 31 August 2010 (August data appear to have the latest updates available online) if the original MDA was submitted in May as Biotronik suggests. Does it really take this long to review MDA's before they are published? It is one thing to verify an MDA from the public before publishing on the FDA MAUDE database, but a manufacturer's MDA regarding their own device should be published without delay.

I am not sure how you became Biotronik's press release department but irregardless of that, thanks for the follow up. The men you spoke to are gifted salesmen who are incredible at spinning this into an issue of them complying to the FDA. I find it unbelievable that they did nothing to hide this. They have never provided a copy of this report to their own force. The pictures which tell the story of the patient were never to be disseminated to the world or so they thought. This issue goes beyond the 2 men you met with and goes to Berlin. If this case study is ever released again, and I doubt it will be, the pictures will not be attached to the story about "venting". Remember this is the same company that were training cardiologists just to put in more ICD's. Leopards don't change their spots.

I agree that these are talented men who would not be in the position they are in if they couldn't sway some opinion. Ever heard of the saying "Sell ice to an Eskimo?" Of course you have, and that is what they are attempting to do here. They are trying to shift focus away from the cover up, by saying that they reported this all to the FDA and are compliant with all regulations. I am sure that they have filled out the paperwork. I think the issue here is the pressure that has been placed on Dr. Hudec from the industry. The quick retraction of a scientific paper and his trite follow up and almost apology are marked by a stench of cover up and deceit. They can release all the internal memos they want through a social blogger, it doesn't change the fact that this looks like a cover up.

Thank you for your attention to doing the right thing throughout this process. You got some "let's kill the messenger" reaction, but you are appreciated as well. I'm sure you never thought a simple informative posting would cause so much grief. Good luck and good karma your way!

It's unfortunate that they resort to the "this has happened to all manufacturers" line which is an attempt to throw all the technology into a single risk bucket. Biotronic uses a different battery chemistry than other ICD manufacturers. Will the re-published case study now be a "series" with undocumented ancedcotes to make this case less notable? I find the explanation incredulous that the author just wanted to help colleagues who may encounter this same rare event, and the media sensationalizing came as a surprise. Let's see, he called it an explosion. What's sensational about that? Oh and he took the device out. That never would have occured to me to do, thank you for helping me out should I encounter this in my practice.

To the commenter stating the following; "Remember this is the same company that were training cardiologists just to put in more ICD's. Leopards don't change their spots." -- EVERY SINGLE CRM company out there, ALL OF THEM were training non-EP's to implant ICD's. My practice was recently approached by one of the "Big 3" to train a brady implanter. Isn't that taboo now? It doesn't appear that Bio tried to hide this. Did they try to soften the blow, sure. Do not kid yourself, every company would have done the same thing. Unfortunately, it does take that long before MDRs are filed on the MAUDE database. That is not Biotronik's doing. That is just how the FDA drags their feet. That database isn't a priority for them. Listen, I am not trying to defend Bio on this. I only use them about 10-15% but they don't spew as much venom as the other guys do. My Bio reps actually carry themselves respectfully. These posts seem to be bashing Bio and I don't think they deserve it.

About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.